PAL · Pulmonic Replacement Heart Valve
Cardiovascular · 21 CFR 870.3925 · Class f
Overview
| Product Code | PAL |
|---|---|
| Device Name | Pulmonic Replacement Heart Valve |
| Regulation | 21 CFR 870.3925 |
| Device Class | Class f |
| Review Panel | Cardiovascular |
| Implant | Yes |
| Life-Sustaining | Yes |
Identification
A replacement heart valve is a device intended to perform the function of any of the heart's natural valves. This device includes valves constructed of prosthetic materials, biologic valves (e.g., porcine valves), or valves constructed of a combination of prosthetic and biologic materials.
Classification Rationale
Class III (premarket approval).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
